Transvaginal Mesh Guidelines Created by AHRQ Ignored by FDA
April 27, 2012 Posted by: Barb Stephens
The vaginal mesh helpline and Vaginal mesh lawyers are happy to see the AHRQ has released guidelines for Mesh Surgery. Women call daily with severe complications from their vaginal mesh implant. The FDA has offered nothing. Even with the guidelines the horrors of the Vaginal mesh cannot be denied.From listening to women every day it is becoming obvious that the transvaginal mesh is dangerous. Women nationwide have filed lawsuits against several vaginal mesh manufacturers, including Johnson and Johnson and Boston Scientific. Hundreds of these cases have been consolidated in a multidistrict litigation (MDL) in the West Virginia district court.It appears that many more will be added over the next months yet doctors are still putting the mesh in women. Many women call our helpline just months after their surgery with severe discomfort and complications.
Even before the U.S. Food and Drug Administration (FDA) issued warnings against the continued use of transvaginal mesh in patients suffering from pelvic organ prolapse, another governmental agency set its sights on the faulty medical device.The U.S. Agency for Healthcare Research and Quality (AHRQ), which is a branch of the U.S. Department of Health and Human Services, released guidelines for patients considering having the questionable medical device implanted. The guidelines also remind doctors that transvaginal mesh is a new procedure and should be used with caution.
The agency, formerly known as the Agency for Health Care Policy and Research, is the research arm of health and human services. It acts as a regulatory agency for patient safety organizations. In its guidelines for utilizing transvaginal mesh, the agency recommended that doctors, surgeons and nurses be adequately trained in using the device to fix pelvic prolapse before implanting it.
Pelvic prolapse is known to occur in women who are past menopause and childbearing years or who have had a hysterectomy. Because of weakened muscles, the pelvic organs, including the uterus and rectum, can slip into the vagina and cause a host of problems. Agency for Healthcare Research and Quality
Doctors were using transvaginal mesh to fix the problem, but many now realize the all of the transvaginal mesh devices on the market are modeled after one that is faulty in design. This faulty design results in mesh erosion.
Because of this, thousands of women are suffering from injuries that include bleeding, immense pain and punctured internal organs. Many women are forced to have the mesh removed in an attempt to lead a normal, pain-free life.
The FDA’s response to transvaginal mesh has been shoddy at best. In 2008, the agency downplayed patient’s complaints about the mesh, saying problems with it is rare.
Three years later, the FDA did a rare reversal and said that problems with the device are “not rare.” However, nothing has been done to regulate the faulty devices or the manufacturers.
In the years between the two FDA decisions, the AHRQ came out with its guidelines for patients. The agency said patients need to be aware of several issues:
- Transvaginal mesh is considered new way to treat pelvic prolapse, thus not proven.
- Success rates vary.
- There is little information about long-term use.
- Serious complications could result from mesh.
- Little data exists that transvaginal mesh will actually fix a prolapse problem.
- Patients should undergo thorough pre-operative counseling regarding the limited data that exists about the device.
With the mounting medical evidence showing that transvaginal mesh is dangerous, women nationwide have filed court complaints against several mesh manufacturers, including Johnson and Johnson and Boston Scientific. Hundreds of the cases have been consolidated in a multidistrict litigation (MDL) in a West Virginia district court. Contact the Vaginal Mesh helpline to get the facts, get help locating a Doctor for Mesh removal and be connected to an experienced vaginal mesh , mass tort lawyer.